The ReCerf® Hip Resurfacing device has been extensively
laboratory tested where the device was subjected to loads far in
excess of those expected in a patient’s own body such as falls
(stumbling) and traumatic events such as head-on car crash to
evaluate its performance limitations. Mechanical testing and state
of-art finite element analysis (computer modeling) investigated all
aspects of performance of the device such as static and fatigue
limits, joint simulator wear testing including micro-separation, head
and cup fixation and predictive bone remodeling.
All testing meets or exceeds the design parameters.
Additionally, the fixation coating type is one that has been used for
many years on metal total hip implants and exceeds all test
standards. The ceramic material used in the components of the
device has been used in total hips over 20 years and is supplied by
the world leader in ceramic material (Ceramtec).
As discussed above because ReCerf® is a new device, it does not
yet have enough clinical data to predict all outcomes and no-one
can know what unexpected issues may arise until a dataset of
clinical evidence has been accumulated, THE FIRST 2-5 YEAR DATA
LOOK EXCELLENT.
The first ReCerf® device was implanted on 24th September 2018
and more than 1000 have been implanted since then. All patients
continue to do well and their consultant’s report show no issues
with the device. Patients are being followed up closely to ensure
the continued success of the device and early reporting of any
unexpected issues. Dr.De Smet has done over 320 implants, in 5
years.